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Questions and Answers
What is the primary objective of the Administrative Order mentioned?
What is the primary objective of the Administrative Order mentioned?
- To ban certain herbal medicines
- To enhance pharmaceutical sales
- To rationalize labeling requirements (correct)
- To increase drug prices
The Administrative Order applies only to manufacturers of conventional drug products.
The Administrative Order applies only to manufacturers of conventional drug products.
False (B)
What does API stand for?
What does API stand for?
Active Pharmaceutical Ingredient
An __________ is responsible for the physiological action of a drug substance.
An __________ is responsible for the physiological action of a drug substance.
Match the following terms with their definitions:
Match the following terms with their definitions:
Which entity is NOT included under the scope of the Administrative Order?
Which entity is NOT included under the scope of the Administrative Order?
The Administrative Order can apply to traditionally-used herbal products.
The Administrative Order can apply to traditionally-used herbal products.
What does the term 'noncovalent derivative' refer to?
What does the term 'noncovalent derivative' refer to?
What indicates the name of an API for herbal medicines?
What indicates the name of an API for herbal medicines?
The percentage of alcohol in a product must be specifically indicated.
The percentage of alcohol in a product must be specifically indicated.
What is the equivalent amount of elemental calcium in Calcium Carbonate listed as 750 mg?
What is the equivalent amount of elemental calcium in Calcium Carbonate listed as 750 mg?
The coloring agents used in pharmaceuticals must be indicated, particularly if they may cause __________.
The coloring agents used in pharmaceuticals must be indicated, particularly if they may cause __________.
Match the following drugs with their correct indications:
Match the following drugs with their correct indications:
Which monograph reference indicates the analysis method for a finished drug product?
Which monograph reference indicates the analysis method for a finished drug product?
The labeling materials can include non-FDA approved uses of the drug product.
The labeling materials can include non-FDA approved uses of the drug product.
The API of a drug product must be indicated followed by its corresponding __________.
The API of a drug product must be indicated followed by its corresponding __________.
What does 'Date of Manufacture' refer to?
What does 'Date of Manufacture' refer to?
Dosage strength only refers to the quantity of active pharmaceutical ingredient (API) in the formulation.
Dosage strength only refers to the quantity of active pharmaceutical ingredient (API) in the formulation.
What is a dosage form?
What is a dosage form?
The _____ describes the quantity of medicine given per administration.
The _____ describes the quantity of medicine given per administration.
Match the following terms with their definitions:
Match the following terms with their definitions:
Which of the following is NOT considered a drug product?
Which of the following is NOT considered a drug product?
Herbal drugs are excluded from the definition of drug products.
Herbal drugs are excluded from the definition of drug products.
Name one pharmacopoeia recognized by the FDA.
Name one pharmacopoeia recognized by the FDA.
What does a prodrug require to exert its pharmacological effects?
What does a prodrug require to exert its pharmacological effects?
Prescription drug products can be dispensed without a physician's order.
Prescription drug products can be dispensed without a physician's order.
What is the purpose of precautions when using a drug product?
What is the purpose of precautions when using a drug product?
The ___ of a drug product refers to its name as registered in the FDA.
The ___ of a drug product refers to its name as registered in the FDA.
Match the following terms with their definitions:
Match the following terms with their definitions:
Which of the following best defines 'small containers' in drug packaging?
Which of the following best defines 'small containers' in drug packaging?
The storage conditions of a drug product do not affect its stability.
The storage conditions of a drug product do not affect its stability.
What are examples of small containers in drug packaging?
What are examples of small containers in drug packaging?
What should a drug label include regarding dosage information?
What should a drug label include regarding dosage information?
A drug label must include directions for special populations, such as adults and children.
A drug label must include directions for special populations, such as adults and children.
What should a label state if a drug is not recommended for children?
What should a label state if a drug is not recommended for children?
The label shall include signs and symptoms of __________.
The label shall include signs and symptoms of __________.
Which of the following must be included on a drug label as a precaution?
Which of the following must be included on a drug label as a precaution?
Match the interaction type with its description:
Match the interaction type with its description:
The label should include only positive effects of the drug.
The label should include only positive effects of the drug.
What additional information should be included on the label concerning adverse drug reactions?
What additional information should be included on the label concerning adverse drug reactions?
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Study Notes
Objective
- Aim to harmonize generic labeling rules and regulations for drug products in line with ASEAN Member States.
- Provides updated guidelines for manufacturers and distributors.
Scope
- Applies to all drug product manufacturers and distributors, including herbal medicines and traditional herbal products for human use.
Definition of Terms
- Active Moiety: The molecule responsible for the drug's physiological action, excluding certain noncovalent derivatives.
- Active Pharmaceutical Ingredient (API): The active compound used in pharmaceutical product manufacturing.
- Dosage: The amount of medication given per administration.
- Dosage Form: The type of drug presentation (e.g., tablet, capsule, cream).
- Dosage Strength: Typically refers to API concentration or potency expressed according to recognized pharmacopoeia standards.
Drug Product Classification
- Recognized by various pharmacopoeias (e.g., USP, BP, EP).
- Intended for diagnosis, treatment, or prevention of diseases.
- Includes herbal/traditional drugs recognized in the Philippine National Drug Formulary.
Labeling Requirements
- Product Name: Generic and brand names as registered with FDA.
- Summary of Ingredients: Must list active ingredients with their respective amounts, followed by the relevant monograph reference.
- Indications: Only FDA-approved clinical uses can be stated.
Precautions and Warnings
- Label must include precautions for safe use and avoid adverse effects.
- Specific warnings required by FDA, such as "flammable" or "for external use only."
Dosage and Administration
- Comprehensive information on recommended dosages, frequency, adjustments, and special considerations for children or specific populations.
Interactions
- Label must disclose potential drug-drug, drug-food, and drug-laboratory interactions.
Adverse Drug Reactions
- Detailed information about possible adverse effects classified by organ system must be included on the label.
Overdose Information
- Signs and symptoms of overdose, as well as recommended treatment measures, should be clearly stated on the label.
Storage Conditions
- Clear specifications for the storage environment needed to maintain drug stability based on laboratory data.
Small Containers Definition
- Small containers defined as holding ≤5 mL or 5 g, including various types of vials, jars, and tubes.
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